CAB
ISO/IEC 17025 identification n°
ISO/IEC 17020 identification N°
ISO/IEC 17065 identification N° / /
Please update the table of contents before closing the document
Table of contents
Name of the assessed CAB 2
Table of contents 3
Assessment program 4
Attendance list opening meeting/closing 5
Summaries and conclusions of assessment 6
Lead assessor: NAME First name 6
Technical assessor: NAME First Name 13
Finding n°: initiales + x/y 19
Corrective action n°: initiales + x/y 20
Scope of accreditation validated for a testing laboratory 21
Scope of accreditation validated for a calibration laboratory 22
Scope of accreditation validated for an inspection body 23
Scope of accreditation validated for a product certification body 24
Name of the assessed CAB
Type of assessment
(ex: P1S1+E1)
According to standard ISO/IEC 17025: 2005
«General requirements for the competence of testing and calibration laboratories»
(File no 20xx/x/0xx)
(ex: P1S1+E1)
According to standard ISO/IEC 17020: 2012
«Requirements for the operation of various types of bodies performing inspections»
(File no 20xx/x/0xx)
(ex: P1S1+E1)
According to standard ISO/IEC 17065:2012
«Requirements for bodies certifying products, processes and services»
(File no 20xx/x/0xx)
Please find all necessary information with regard to the type of audit and file noon your mission order
Table of contents
Notified body: / Yes No / Directive(s)/regulation assessed:The audit may cover one or more standards (please delete tables which are not necessary)
Accreditation standard / Type of assessment / Assessment date(s):ISO/IEC 17025 / Granting (initial) / Extension
surveillance / Additional
renewal
Accreditation standard / Type of assessment / Assessment date(s):
ISO/IEC 17020 / Granting (initial) / Extension
surveillance / Additional
renewal
Accreditation standard / Type of assessment / Assessment date(s):
ISO/IEC 17065 / Granting (initial) / Extension
surveillance / Additional
renewal
Area of accreditation:
Composition of the assessment team and job description of the assessors
LA = Lead Assessor, TA = Technical Assessor, Expert = E, JA = Junior Assessor
Name + First name of the assessor / Function / Assessed activities (code(s): see mission order)
Assessment program
For initial assessments: please note date of documentary review by LADate and time: / Reference section: / Names of assessors: / Persons encountered: /
Opening meeting
- Presentation of assessors and participants,
- Confirmation of rules of confidentiality ,
- The audit objectives and criteria for accreditation,
- Review of the scope of accreditation,
- Approval of the audit plan,
- Evolution since last assessment (organisation, MQS, equipment,…) / See form F003g
Lead assessor / Quality assessor
Technical assessor / Responsible technical assessor/technical assessor
If necessary, exchange of point of views of audit team members / Audit team / /
Lunch break
If necessary, exchange of point of views of audit team members / Audit team / /
Set up of possible findings,
Preparation of the closing meeting / Audit team / /
Closing meeting
- Presentation of findings and signature/approval of findings,
- Presentation and comments with regard to the summary audit report,
- Fix final date for reception of corrective actions (max. 15 work days),
- Define changes to be realized to the scope of accreditation (if applicable)
- Inform CAB of next steps with regard to accreditation procedure. / See form F003G
Remark: Planning of the different phases of the management system audit and technical audit is likely to adjustments depending on constraints of the planning of the body which will be specified during the opening meeting
Attendance list opening meeting/closing
Opening meeting: / check the box / Meeting date:Closing meeting / check the box
CAB’s audited personnel / Function / Signature /
Original signed
Assessors / Function (LA, TA, E, JA) and technical domain / Signature /
Original signed
Summaries and conclusions of assessment
Lead assessor: NAME First name
Summary of the lead assessorPlease fill out all boxes below mentioning your observations and related assessment evidences.
For all not examined or not applicable points, please state this clearly in the corresponding field.
Important amendments since the previous assessment
Legal structure and description of the activities of the organization
(§ 4.1 ISO 17025 - § 5.1 ISO 17020 - § 4.1.1 et § 5.1 ISO 17065)
Impartiality (including the description of relations that could affect impartiality and means of control), independence and confidentiality
(§ 4.1.5.b/c/d ISO 17025 - § 4.1 et § 4.2 ISO 17020 - § 4.2 et § 4.5 ISO 17065)
General and functional organization (organization chart, positioning in the structure, management, job descriptions, substitution)
(§ 4.1.5 ISO 17025 - § 5.2 ISO 17020 - § 5.1 ISO 17065)
Quality manager and technical manager (roles and responsibilities)
(§ 4.1.5.h/i ISO 17025 - § 5.2.5 et 5.2.6 ISO 17020)
Management of staff competence (contract, training, qualification, authorization, competence and performance, records…) (§ 5.2 ISO 17025 - § 6.1 ISO 17020 - § 6.1 ISO 17065)
Installations (access, ambient conditions if applicable, maintenance) (§ 5.3 ISO 17025 et § 6.2 ISO 17020)
Purchase (purchase data, supplier, services and good selection and evaluation, purchase, storage and record control …) (§ 4.6 ISO 17025 - § 6.2.11 ISO 17020)
Equipment (identification, calibration and monitoring of measurements (A016), reference standards of measurements, computer or automated equipment, defective equipment, equipment files …)
(§ 5.4 et 5.6 ISO 17025 - § 6.2 ISO 17020)
Subcontracting (competent/accredited, contract + confidentiality and impartiality, information of clients, records)
(§ 4.5 ISO 17025 - § 6.3 ISO 17020 - § 6.2.2 ISO 17065)
Complaints and appeals (§ 4.8 ISO 17025 - § 7.5 et 7.6 ISO 17020 - § 7.13 ISO 17065)
Requirements with regard to Management System of the CAB
- Policies and objectives: (§ 4.2.2 ISO 17025 - § 8.2.1 ISO 17020 - § 8.2.1 ISO 17065)
- Management system and document control: (§ 4.2 et § 4.3 ISO 17025 - § 8.2 et 8.3 ISO 17020 - § 8.2 et 8.3 ISO 17065)
- Record control: (§ 4.13 ISO 17025 - § 8.4 ISO 17020 - § 8.4 ISO 17065)
- Management review: (§ 4.15 ISO 17025 - § 8.5 ISO 17020 - § 8.5 ISO 17065)
- Internal audits: (§ 4.14 ISO 17025 - § 8.6 ISO 17020 - § 8.6 ISO 17065)
- Improvement and corrective/preventive actions: (§ 4.10 à 4.12 ISO 17025 - § 8.7 et 8.8 ISO 17020 - § 8.7 et § 8.8 ISO 17065)
F Special provisions for laboratories
Communication (§ 4.1.6 et 4.2.4)
Service to the customer (§ 4.7)
Control of nonconforming testing and/or calibration work (§ 4.9)
Technical records (§ 4.13.2)
Requirements with regard to process realization
(please indicate list of assessed files – vertical traceabiliy)
- Review of requests, tenders and contracts: (§ 4.4)
- Test and calibration methods and method validation: (§ 5.4)
- Management of flexible scopes (if applicable): (Annexe A012)
- Sampling: (§ 5.7)
- Handling of test and calibration items: (§ 5.8)
- Assuring the quality of test and calibration results: (§ 5.9)
- Reporting the results: (§ 5.10)
F Special provisions for inspection bodies
Administrative requirements
- Insurance and accounts: (§ 5.1.4)
Requirements with regard to process realization
(please indicate list of assessed files – vertical traceabiliy)
- Inspection methods and procedures: (§ 7.1)
- Contract and work order control system: (§ 7.1.5)
- Handling inspection items and samples: (§ 7.2)
- Record system: (§ 7.3)
- Inspection reports and inspection certificate: (§ 7.4)
F Special provisions for product, process and service certification bodies
General requirements
- Certification agreement: (§ 4.1.2)
- Use of license, certificates and marks of conformity: (§ 4.1.3)
- Liability and financing: (§ 4.3)
- Non-discriminatory conditions: (§ 4.4)
- Publicly available information: (§ 4.6)
Structural requirements
- Mechanism for safeguarding impartiality: (§ 5.2)
Requirements with regard to process realization
(please indicate list of assessed files – vertical traçeabiliy)
- Assessed certification program:
- Application and application review: (§ 7.2 + § 7.3)
- Evaluation: (§ 7.4)
- Review and certification decision: (§ 7.5 + § 7.6)
- Certification documentation: (§ 7.7)
- Directory of certified products: (§ 7.8)
- Surveillance: (§ 7.9)
- Changes affecting certification: (§ 7.10)
- Termination, reduction, suspension or withdrawal of certification: (§ 7.11)
- Records: (§ 7.12)
Respect of applicable EA, IAF and ILAC requirements: see annex A006 – applicable standards and guidlines
Respect of the guidelines for the use of the OLAS logo: see annex A003 – Guidelines for the use of the OLAS logo
Control of corrective actions of the previous assessment:
Please check also the intermediary report of the CAB regarding implementation of corrective actions.
Just mention those findings which have not been closed in the table
Identification n° of the finding from the previous assessment / Identification n° of this assessment’s finding / Comment:
-
Additional comments (if significant):
Strong areas:
Sensitive areas:
Final conclusions of lead assessor on improving the efficiency of the quality system:
Clear statement of the lead assessor as to the granting, maintaining, withdrawing, etc. of accreditation status::
Validation of the accreditation scope and the granted flexibility (if applicable) by the team in collaboration with the CAB before publication:
Thank you for specifying changes of the accreditation scope, if applicable.
Persons encountered:
NAME- First name / Function - Service
List of assessed files (vertical traceability):
Do not forget to complete the summary sheet of all verified criteria (F017)
F For a notified body: (see A019)Directive(s) or Regulation(s) assessed - Assessed module(s) / annexes/ article(s)/ system
Please indicate for each directive/regulation, the modules, annexes, articles and systems assessed.
Specific competence of the personal linked to the directive / regulation
Integration of conformity assessment procedures in the MQS
Participation in standardization activities and coordination groups (if applicable)
Information obligation towards the notifying authority and other notified bodies
Final conclusions of the lead assessor on technical competences of the notified body regarding the requirements of the conformity assessment procedures concerned by the notification:
Do not forget to complete the summary sheet of all verified criteria (F017)
Technical assessor: NAME First Name
Technical domain(s) assessed:Summary of the technical assessor:
Please complete all boxes below, mentioning your observations and related assessment evidences.
With regard to non-assessed points or if not applicable, please do state this clearly in the corresponding field.
List of methods or inspection/certification standards checked during this assessment
Management of staff competence (contract, training, qualification, authorization, competence and performance, records…) (§ 5.2 ISO 17025 - § 6.1 ISO 17020 - § 6.1 ISO 17065)
Subcontracting (competent/accredited, contract + confidentiality and impartiality, information of clients, records)
(§ 4.5 ISO 17025 - § 6.3 ISO 17020 - § 6.2.2 ISO 17065)
F Special provisions for laboratories
Installations (access, ambient conditions, if applicable, maintenance) (§ 5.3)
Validation and verification of methods (§ 5.4.5) (A011).
Approach for evaluation of uncertainty measurements associated to the scope of accreditation (§ 5.4.6).
Equipment (identification, calibration and monitoring of measurements (A016), reference standards of measurements, computer or automated equipment, defective equipment, equipment files …) (§ 5.5 et § 5.6)
Sampling procedure and check the management of non-conform samples (§ 5.7).
Handling of test and calibration items (§ 5.8)
Participation for inter laboratory comparisons, frequency of participation, results obtained, corrective actions and other proofs of their competence in case of non-participation (§ 5.9) (A015 et F023).
Result reporting (§ 5.10)
Observation on realization of tests/calibration and/or on-site sampling
- Tests/calibration and/or observed sampling:
- Observed personnel:
- Statement of observation:
Provisions on management of flexibility of the accreditation scope (if applicable) (A012).
F Special provisions for inspection bodies
Equipment (identification, calibration and monitoring of measurements (A016), reference standards of measurements, computer or automated equipment, defective equipment, equipment files (§ 6.2)
Inspection methods and procedures (§ 7.1)
Handling inspection items and samples (§ 7.2)
Records (§ 7.3 et § 8.4)
Inspection reports and inspection certificates (§ 7.4)
Observation on realization of on-site inspection
- Observedinspection:
- Observed personnel:
Statement of observation:
- Mission preparation (design and documentation of mission, planning, qualification of inspectors):
- Inspection realization (method and procedures, use of check-lists, relevance of findings and recording…):
- Feed-back to client (inspection report):
F Special provisions product, process and service certification bodies
Equipment (identification, calibration and monitoring of measurements (A016), reference standards of measurements, computer or automated equipment, defective equipment, equipment files
Application and application review (§ 7.2 et § 7.3)
Evaluation (§ 7.4)
Review and certification decision (§ 7.5 et § 7.6)
Certification documentation (§ 7.7)
Directory of certified products (§ 7.8)
Surveillance (§ 7.9)
Changes affecting certification (§ 7.10)
Termination, reduction, suspension or withdrawal of certification (§ 7.11)
Records (§ 7.12)
Observation of realization of an on-site audit/certification on site
- Observed audit/certification:
- Observed personnel:
Statement of observation:
- Mission preparation (design and documentation of mission, planning, qualification of personnel):
- Certification realization (method and procedures, use of check-lists, relevance of finding and recording…)
- Feed-back to client (audit report/certification):
Respect of applicable EA, IAF and ILAC requirements: see annex A006 – Normes et guides applicables
List of assessed EA, ILAC et IAF documents:
Comment:
Control of corrective actions of the previous assessment:
Please also check the intermediary report of the CAB, regarding the implementation of corrective actions.
Just mention those findings which have not been closed in the table.
Identification n° of the finding from the previous assessment / Identification n° of this assessment’s finding / Comments:
-
Additional comments (if significant):
Strong areas:
Sensitive areas:
Final conclusion of the technical assessor regarding the technical competencies of the audited body
Persons encountered domains of the assessed scope:
The below mentioned technical domains have to be taken from the accreditation scope.
Name – First name / Function - Service / Technical domain(s) (see A005)
List of assessed files (vertical traceability):
Do not forget to complete the summary sheet of all verified criteria (F017)